Navigating Patent Law

Three Section 101 decisions from the Federal Circuit this past week -- all invalidating computer-related patents with pre-2014 filing dates. In GoTV v. Netflix, the court reversed a $2.5 million jury verdict, finding that claims for tailoring content display to wireless device capabilities were directed to abstract ideas despite terms carrying what Judge Taranto called a "first-blush appearance of technical specificity." In Innovaport v. Target, all 55 asserted claims invalid — including patents that had overcome Section 101 rejections during prosecution. And in Q Technologies v. Walmart, location-based content sharing claims met the same fate. Two takeaways with a bit of nuance. First, I am recognizing in myself an expectation that pre-Alice patents are inherently suspect on eligibility. Patents drafted before 2014 were written under a legal regime where Section 101 was effectively dormant for software and business method claims. Specifications from that era routinely described problems in business terms and solutions in generic technological ones. That made sense at the time. But the approach fails under Court scrutiny. Second, the Federal Circuit has largely rejected attempts to use prosecution history to support eligibility. In Innovaport, two patents overcame Section 101 rejections by adding cross-referential product linking limitations. Those very features were then held to be part of the abstract idea itself. The court cited Sanderling v. Snap for the proposition that courts need not defer to PTO eligibility determinations. In GoTV, the only Section 101 rejection encountered during prosecution addressed transitory signals — not Alice-type abstractness at all and again no deference given. But here's what I think practitioners and the courts are missing: these rejections of prosecution history are primarily rejections of conclusory showings. Neither GoTV nor Innovaport built a factual record during prosecution that documented why specific claimed features were unconventional. The amendments satisfied examiners but created nothing for courts to work with at Alice step two. I believe there is space for patent prosecutors to build meaningful factual records during prosecution — declarations, technical comparisons, detailed explanations of what makes the claimed approach different from conventional implementations. I also believe that there is a role here for examiner reasons for allowance focusing on the eligibility issue. The Federal Circuit has been saying that conclusory assertions carry no weight - but they have not expressly opined on non-conclusory prosecution history evidence. This matters even more given the growing gap between the USPTO's increasingly permissive eligibility standards under Director Squires and the Federal Circuit's unchanged doctrine. Claims that clear the agency bar will still face a reckoning in court. One answer is to build the record now. Link in the comments.

A granted patent does NOT give you the right to launch your product. Here is the legal trap most generic companies fall into. One of the most dangerous misconceptions in the pharmaceutical industry is confusing Patentability with Freedom to Operate (FTO). Here is the difference every R&D head, founder, and IP manager must know: Patentability Search: Question Asked: "Is my new formulation, process, or delivery method novel and inventive?" Focus: Securing your own patent rights from the Patent Office. Freedom to Operate (FTO) Search: Question Asked: "Does launching my commercial product infringe on anyone else's valid patent in the target market?" Focus: Preventing multi-million-dollar patent infringement lawsuits. The Reality Check: You can hold a valid, granted patent for an innovative injectable formulation, but if a competitor holds a broader patent on the active ingredient or container-closure system, you cannot launch without a license. Key Takeaway: Patentability gives you a weapon; FTO gives you a green light. Never confuse the two before setting your commercial launch date! 👉 Master product selection and FTO strategy: Subscribe to Simplify IP With Sanjay on YouTube for actionable pharma IP insights: (Link is below in first comment) Like, comment, Share and SUBSCRIBE if you find it helpful. #pharma #patent #iplaw #ipstrategy #genericpharma #pharmaceutical #patentcliff #patentwar #biotech #ipchecklist #simplifyipwithsanjay #excelonip

Patents don’t make you untouchable. Speed does. 🏎️   Thankfully, I avoided wasting money early on this. Back in 2016, I invented the thinnest, most protective phone case on the planet for my company Mous. A real breakthrough. My first thought? “What if someone copies this?”   No problem, the patent system exists to protect innovation, right? Debatable...   We looked at the market. We looked at our competition. And we made a decision that went against every instinct I had as an inventor.   We didn’t file a patent.   Here's why: ▪️ Patents don’t stop copying: you don’t get automatic protection. You get the right to spend years in court proving someone copied you. ▪️ Most investors don’t fully grasp patents: 90% ask if you have one. 99% don’t understand if it’s actually enforceable. ▪️ Patents are a gamble: A patent examiner (a human) has to decide if your idea is unique. If they miss something, you could spend years and £££ only to find out your patent isn’t even valid. Instead of a patent, we focused on speed - building the brand, dominating the market, and making it impossible for knockoffs to catch up.   It worked!   Five years later, fake versions started appearing. But by then, we were big enough to fight back. And my mantra: if you're getting copied, you're doing something right.   Lesson learned: If you’re building hardware, ask yourself: Do I need a patent, or do I just need to move faster? 🤔   Would love to hear from other founders and entrepreneurs on this. Did patents help you, or was it just expensive paperwork?

Stockpiling under Indian Patent Law: Position, Challenges, and Springboard Damages As we know, stockpiling in patent law refers to manufacturing and accumulating patented products during the patent term to enable immediate post-expiry launch, gaining a market advantage. While Europe permits limited “stockpiling exemptions” under the Supplementary Protection Certificate regime, India does not have any such statutory stockpiling exemption. India’s Bolar-like exemption under Section 107A of the Patents Act, 1970 only allows limited use of a patented invention for obtaining regulatory approvals before expiry, without authorisation from the patentee. While this provision facilitates timely generic entry upon expiry while respecting the patentee’s exclusive rights under Section 48, it does not permit stockpiling of commercial quantities during the patent term, as this would erode the exclusivity guaranteed to the patentee. In E.R. Squibb vs. Zydus Lifesciences (CS(COMM) 376/2024, Delhi High Court), the court clarified the scope of Section 107A vis-à-vis stockpiling. Squibb demonstrated Zydus’ pattern of imports and accumulation of Nivolumab over multiple years, including immediately before patent expiry, which they argued indicated stockpiling under the guise of regulatory preparations. Zydus argued this was within the Bolar exemption, but the court held that Section 107A does not extend to manufacturing or importing quantities for commercial stockpiling. The court viewed the timing, repeated imports, and proximity to patent expiry as indicative of preparations for a launch, thereby restraining Zydus through an interim injunction. In the wake of this judgement, every export/import could be subject to microscopic examination and perhaps, a good paper trail may be a saviour. The future- Given the absence of a statutory exemption: Any manufacturing/importing beyond quantities strictly required for regulatory approvals constitutes infringement. Courts should adopt a fact-specific analysis assessing: Quantities imported/manufactured. Timing relative to expiry. Alignment with regulatory needs. Evidence of marketing or launch preparation. This approach maintains the balance between facilitating generic entry post-expiry and preserving patent exclusivity during the patent term.

An expensive patenting mistake: One of the many reasons given for AstraZeneca pausing investment in the UK and considering moving its stock listing to the US was the cancellation of two SPCs linked to the patent for the antidiabetic agent dapagliflozin. As the NHS spends £300 million per year on this drug, the financial fallout to AZ will be immense. Why did this happen? Simply put, there wasn't any data on drug activity in the patent specification, therefore the patent is invalid for both lack of inventive step and insufficient disclosure. How this was missed in drafting and later in due diligence is a mystery, but it teaches us the following: (1) When drafting a patent application, especially for therapeutics, it's crucial to go beyond simply claiming a technical effect. You must provide data that makes the effect plausible. Since clinical data is often unavailable early on, include preclinical, in vitro, or in silico data to support your claims. Keep in mind you don't need to definitively prove your invention works, but the application must contain enough information for a skilled person to reasonably believe it would. This is known as plausibility. While you can use a priori reasoning or reference prior art to establish this, be careful not to make the invention seem obvious, as this could compromise its patentability. (2) For due diligence, carefully assess the data supporting a patent portfolio. The data must be robust and commensurate with the claims' scope. Patents that merely assert a technical effect without providing experimental results are vulnerable to attacks based on inventive step or sufficiency under current UK and European Patent Office standards. Therefore, having solid data is essential for a strong, defensible patent. https://lnkd.in/ea6tF9si

A few people asked what it actually looks like to file patent applications the smart way. Here’s the framework I give startup teams who want to protect innovation without wasting capital: 1. Don’t file just because you “can.” Too many patent applications get filed on features that aren’t core to the product, the market, or the long-term strategy. Just because it’s technically new doesn’t mean it’s worth protecting. 2. Tie every filing to a business objective. What are you trying to accomplish? Protect revenue? Block a competitor? Support a valuation narrative? There needs to be a clear business case for every dollar spent on IP. 3. Prioritize enforceability over imagination. Broad, abstract patents might sound exciting, but they often fail when tested. Focus on what you can realistically enforce. If your claim can’t stand up in court or deter a competitor, it’s not helping you. 4. Treat foreign filings like investments — not checkboxes. Filing internationally gets expensive fast. File where you have customers, competitors, or partners. Not where “you might want protection someday.” 5. Reassess regularly. As your product evolves, your patent strategy should too. What mattered at seed stage may not matter at Series B. Trim the fat. Redirect capital where it matters. The bottom line: a strong patent strategy isn’t about quantity — it’s about alignment. The best portfolios are lean, targeted, and tied directly to how the company competes and grows. If you’re not sure whether your IP is doing that, it’s worth a second look.

This prior art search saved my inventor from filing a weak patent. A Nutritionist came to me with a baby milk formulation, poured years into. Countless trials. Sleepless nights. Absolute belief it was novel. Before filing, we ran a prior art search.What showed up was uncomfortable: 🍼 Similar nutrient ratios. 🍼Overlapping compositions. 🍼Old disclosures hiding in plain sight. If we had filed that patent as-is, it would’ve looked impressive and been dangerously weak.Instead, the search forced clarity. We rebuilt the invention around what was truly new and drafted claims that could actually survive scrutiny in the baby milk formulation space. The filing went from hopeful to defensible. CTA: Before you spend money filing, spend time understanding. If you’re building in food, nutrition, or infant formula run a prior art search before you fall in love with your patent idea. Weak patents cost more than strong searches.

𝗔 𝗽𝗿𝗼𝘃𝗶𝘀𝗶𝗼𝗻𝗮𝗹 𝗽𝗮𝘁𝗲𝗻𝘁 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗶𝘀 𝗹𝗶𝗸𝗲 𝗮 𝗽𝗮𝗿𝗮𝗰𝗵𝘂𝘁𝗲—𝗶𝘁 𝗼𝗻𝗹𝘆 𝘀𝗮𝘃𝗲𝘀 𝘆𝗼𝘂 𝗶𝗳 𝗶𝘁'𝘀 𝗳𝘂𝗹𝗹𝘆 𝗽𝗮𝗰𝗸𝗲𝗱. "File a provisional—it's quick and cheap!" This advice destroys more patents than any examiner rejection. Here's what happens too often: • Company A rushes a two-page provisional before their investor demo. It describes their "AI-powered analytics platform" in marketing terms. No technical details. No implementation specifics. Cost saved: $10,000.    • Company B invests two extra weeks creating a complete provisional with technical architecture, algorithms, and multiple implementations. Cost: $15,000.    One year later, both convert to nonprovisional patent applications. Fast forward to patent litigation or acquisition due diligence: • Company A's patent gets invalidated—their provisional didn't "sufficiently describe" what they're claiming • Company B's patent survives every challenge That $5,000 "savings"? It just cost Company A everything. The provisional trap has three lethal variations: 𝗧𝗵𝗲 "𝗡𝗮𝗽𝗸𝗶𝗻 𝗦𝗸𝗲𝘁𝗰𝗵" 𝗧𝗿𝗮𝗽: Filing slideshows, marketing materials, or back-of-napkin drawings. Courts require enough detail that someone skilled in your field could build your invention. Your investor pitch deck doesn't qualify. 𝗧𝗵𝗲 "𝗞𝗶𝘁𝗰𝗵𝗲𝗻 𝗦𝗶𝗻𝗸" 𝗧𝗿𝗮𝗽: Dumping every document into a provisional without connecting them to specific claims. Volume doesn't equal validity. 𝗧𝗵𝗲 "𝗘𝘃𝗼𝗹𝘃𝗶𝗻𝗴 𝗜𝗻𝘃𝗲𝗻𝘁𝗶𝗼𝗻" 𝗧𝗿𝗮𝗽: Your product pivots significantly after filing, but you can't add new matter to claim priority. That provisional now protects something you don't sell. Two solutions that actually work: 1. 𝗙𝗶𝗹𝗲 𝗻𝗼𝗻𝗽𝗿𝗼𝘃𝗶𝘀𝗶𝗼𝗻𝗮𝗹 𝗽𝗮𝘁𝗲𝗻𝘁 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝘄𝗵𝗲𝗻 𝗽𝗼𝘀𝘀𝗶𝗯𝗹𝗲. Yes, they cost more upfront. They're also much less like to explode later. 2. 𝗜𝗳 𝘆𝗼𝘂 𝗺𝘂𝘀𝘁 𝗳𝗶𝗹𝗲 𝗮 𝗽𝗿𝗼𝘃𝗶𝘀𝗶𝗼𝗻𝗮𝗹 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻, 𝗺𝗮𝗸𝗲 𝗶𝘁 𝗮𝘀 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗮𝘀 𝘆𝗼𝘂 𝗰𝗮𝗻. Include architecture diagrams, code snippets, alternative implementations, use cases. Pretend you're explaining it to a competitor's engineering team—because someday, you might be. If you wouldn't jump out of a plane with a hastily-packed parachute, don't bet your company on a hastily-drafted provisional. Need to file fast but file right? Let's talk strategy. #patents #intellectualproperty #startups

A Valid Patent That Couldn't Stop a Generic: The Otsuka v. Lupin Lesson (May 2026) The recent Federal Circuit decision in Otsuka v. Lupin offers an important lesson for pharmaceutical patent strategists. Otsuka asserted two patents covering tolvaptan (JYNARQUE®): US Patent No. 8,273,735 includes process claims directed to using reduced amounts of sodium borohydride during a key reduction step. US Patent No. 8,501,730 includes product-by-process claims directed to highly pure tolvaptan produced using that process. What makes the decision particularly interesting is the different fate of these patents. The Federal Circuit affirmed the district court's determination that the asserted process claims of US 8,273,735 were invalid for obviousness, finding that a skilled chemist would have been motivated to reduce excess sodium borohydride for well-known reasons such as cost reduction, improved safety, simplified work-up, and routine process optimization. However, Lupin failed to prove the asserted product-by-process claims of US 8,501,730 were invalid for obviousness. Yet Otsuka still lost the case because it could not prove that Lupin's proposed ANDA process would infringe the asserted claims. Lupin's DMF disclosed the use of at least 1.2 equivalents of sodium borohydride, while Otsuka's asserted claims required sodium borohydride in the range of 0.25-1.0 equivalents. Otsuka argued that the reaction reached "practical completion" before exceeding the claimed threshold and relied heavily on Lupin's development Experiments 109 and 115 to support that theory. Neither the district court nor the Federal Circuit was persuaded. The experimental data contained anomalies, including observations that appeared inconsistent with the underlying chemistry, leading the court to question the reliability of the experiments. Moreover, the experiments were conducted under conditions different from Lupin's commercial process. As a result, the evidence was insufficient to establish that Lupin's process reached practical completion while still operating within the claimed sodium borohydride range. The outcome is a reminder that: • A process patent based on parameter optimization may be vulnerable to obviousness challenges. • Product related claims may sometimes survive even when corresponding process claims are found obvious. • Most importantly, a valid patent is not enough. Without strong evidence of infringement, even a surviving patent may provide little practical protection against generic entry. This decision also highlights the importance of timely expert challenges, as Otsuka's attack on Lupin's expert qualifications was deemed forfeited because it was not properly raised before or during trial. For innovators, this case highlights the importance of building layered protection around purity claims rather than relying on a single process claim. A patent portfolio is strongest when it can survive both validity challenges and infringement scrutiny. #Lupin

Just in! 💥 Published patent applications deemed prior art in IPRs as of the application’s filing date   Today the Federal Circuit issued its decision in Lynk Labs, Inc. v. Samsung Electronics Co., Ltd., No. 2023-2346, in which the USPTO intervened, resolving the question of whether “a published patent application is deemed prior art in an IPR . . . as of the application’s filing date, or only as of the application’s publication.” Judge Prost, writing for the court and panel which included Judges Lourie and Stark, affirmed the Board’s decision that a published patent application is deemed prior in an IPR as of the application’s filing date. In the IPR’s final written decision on appeal, Samsung’s six grounds of unpatentability relied on a patent application that was filed before the challenged patent’s priority date, but published after (and was abandoned and never matured into a patent). Patentee Lynk Labs challenged the application as not a “prior art . . . printed publication[]” under 35 U.S.C. § 311(b) (emphasis added). Lynk Labs’ primary argument was that to be a prior art printed publication, a publication must be publicly accessible before the relevant date (here the priority date). The court wrote, as a matter of statutory construction, that: "[t]he main problem with Lynk Labs’ argument is that, unlike § 102(a) or (b), and unlike books, articles, or other types of printed publications, Congress created – in § 102(e)(1) – a special rule for published patent applications. Specifically, § 102(e) states (in relevant part): A person shall be entitled to a patent unless— . . . (e) the invention was described in— (1) an application for patent, published under [35 U.S.C. §] 122(b), by another filed in the United States before the invention by the applicant for patent . . . or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent . . . . § 102(e) (emphasis added). Thus, a U.S.-filed patent application 'published under [§] 122(b)' serves as prior art to a claimed invention if the application was 'filed . . . before the [claimed] invention.' Id. § 102(e)(1) (emphasis added)." The court made clear that: “Stated generally: because a published patent application is a ‘printed publication,’ § 102(e)(1) treats this type of printed publication as prior art as of a time before it became publicly accessible—i.e., as of its filing date.” The court addressed Lynk Labs’ other arguments including its discussion of the historical context behind § 311(b) finding that the historical context “only adds further support for the [court’s] plain-language interpretation.” Nice work USPTO, Farheena Rasheed, Michael Forman, Peter Ayers, Amy Nelson, Maureen Queler & the Solicitor Office team!